Improved Diagnostics for Paediatric Tuberculosis
- Conditions
- Tuberculosis
- Registration Number
- NCT06944561
- Lead Sponsor
- St George's, University of London
- Brief Summary
Improved diagnostics for paediatric Tuberculosis
- Detailed Description
Research Question: To test the feasibility of TiKa system to reliably detect Mycobacterium tuberculosis in faeces of paediatric patients with Tuberculosis Study Design: Non-randomised diagnostic proof of concept feasibility study Study Participants: Patients with or suspected to have Tuberculosis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
-
Any patient under the age of 21 years with the following diagnosis for whom informed consent can be obtained will be offered to be included in the trial.
- Latent tuberculosis
- Culture confirmed Tuberculosis
- Clinically suspected Tuberculosis
- Any patient over 21
- Any child or adult/guardian unable to give informed consent
- Any persons under detention will not be included.
- Any patient who is unable to give a sample.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To quantitate the speed of new culture method (TiKa) and compare its efficacy with conventional systems in detecting Mycobacterium tuberculosis in the faeces of paediatric patients with tuberculosis. 2 years Samples will only include faeces (up to 10g) obtained once from outpatients and up to once per day for in-patients.
Faecal samples will be collected and placed into a routine sterile stool collection kit, labelled with a unique identifier allocated from its associated CRF and safe transport arranged to deliver the specimen to the research laboratory. On arrival all samples will be logged and a record kept in a secure locked site by a member of the research team.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CIU Office, St George's NHS Healthcare Trust
🇬🇧London, United Kingdom